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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019381
Receipt No. R000022409
Scientific Title The association analysis between genome modification and physical changes by environmental conditions
Date of disclosure of the study information 2015/10/18
Last modified on 2018/10/24

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Basic information
Public title The association analysis between genome modification and physical changes by environmental conditions
Acronym The association analysis between genome modification and physical changes by environmental conditions
Scientific Title The association analysis between genome modification and physical changes by environmental conditions
Scientific Title:Acronym The association analysis between genome modification and physical changes by environmental conditions
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the relationship between genomic and epigenomic changes and physical conditions.
Basic objectives2 Others
Basic objectives -Others To investigate the relationship between genomic and epigenomic changes and physical conditions.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The methylation of DNA in promoter regions of human genome
WBC, RBC, Hb, Ht, Plt, TG, HDL-Cho, LDL-Cho, AST, ALT, gamma-GTP, BUN, Serum Cr, UA, fasting blood glucose, HbA1c
Key secondary outcomes Height, Body weight, BMI, Boby fat percentage, systolic blood pressure, diastolic blood pressure, Pulse rate, Active mass

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 During eight week trial, subjects perform a normal life.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria 1. Volunteers who participated in the clinical trials carried out in the our research center
2. Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria 1. Subjects who received dietary advice due to disease.
2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities
3.Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
4. Subjects with serious anemia
5. Subjects who are at risk of having allergic reactions to drugs or foods
6. Subjects regularly take medicine
7. Subjects who donate whole blood within 4 weeks or blood components within 2 weeks prior to this study.
8. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial
9. Any other medical reasons judged by the the principal investigator
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Department of Medical Management and Informatics
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4411
Email nishihira@do-johodai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Dir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Organization Hokkaido Information University
Division name Center of Health Information Science
Zip code
Address 59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
TEL 011-385-4430
Homepage URL
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Funding Source
Organization Northern Advancement Center for Science & Technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 08 Day
Last follow-up date
2016 Year 10 Month 14 Day
Date of closure to data entry
2016 Year 10 Month 24 Day
Date trial data considered complete
2016 Year 11 Month 09 Day
Date analysis concluded
2017 Year 03 Month 28 Day

Other
Other related information During trail region, it investigates whether the methylation of DNA changes even if there is no change in eating habits.
It investigates the association between physical conditions and the methylation of DNA.

Management information
Registered date
2015 Year 10 Month 16 Day
Last modified on
2018 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022409

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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